These Guidelines are intended to assist UNT researchers, UNT IRB members, and Office of Research & Economic Development personnel by answering the most frequently asked questions about human subjects research and by briefly explaining the procedures involved in the IRB review process.
If the information you are seeking is not contained in these Guidelines, please contact the IRB at untirb@unt.edu or call the Research Compliance Analyst for Expedited or Full Board Review at 940.565.4643 or the Research Compliance Analyst for Minimal Review (Exempt) Applications at 940.565.4258.
Determining if You Must Have IRB Approval
Determining the Type of Application to Use
Minimal Review
Expedited Review
Full Board Review
Completing the Application
Risks that Must be Clearly Assessed and Described in the Application
Transmit the Completed Application to the IRB
How Applications are Reviewed
Notification of Approval
Changes to Your Study (Modifications)
Adverse Events
Approval Duration
Continuing Renewals
IRB Partial Protocol Approval Before Development of Data Collection Instruments for Funded Projects
Student Theses and Dissertation
Class Projects
Announcement of IRB Studies Not Conducted by UNT
Overview
Required Disclosures
Informed Consent for Non-English Speaking Subjects
Waiver of Documentation of Written Informed Consent
Alteration of Informed Consent
Telephone Surveys
Privacy and Confidentiality
Sample Informed Consent Documents
Additional Safeguards
Students and Coercion
Individuals with Cognitive Impairments
Research Involving Children:
Pregnant Women and Fetuses
Prisoners:
Special Definitions Pertaining to Research Involving Prisoners
Incarceration After Enrollment as a Research Subject
Research In Which A Prisoner Is A Subject Must Fall Within At Least One of These Four Categories
Informed Consent Documentation for Research Involving Prisoners
Prisoners who are Minors